DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF VALSARTAN
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 8
Abstract
Objective: A stability indicating RP-HPLC method was developed and validated for the determination of Valsartan using Telmisartan (10 µg/ml) as the internal standard.Methods: In this procedure Phenomenex ODS C-18(250×4.6 mm, packed with 5 micron) column was used with a new mobile phase consisting of methanol: acetonitrile: water (70:15:15 v/v) and the pH was adjusted to 3 by 0.1% glacial acetic acid with a flow rate of 1 ml/min. The eluents were monitored at 249 nm. Valsartan was subjected to stress conditions including hydrolytic degradation in acidic, basic and neutral conditions, oxidation, photolytic, UV degradation and thermal degradation.Results: Linearity was obtained in the concentration range of 10-90 µg/ml (R2 =0.999) and with a regression equation y=0.074x+0.005. The LOD and LOQ values were 0.261 and 0.791 µg/ml respectively. The drug had shown promising degradation in the acidic, basic, neutral, thermal and oxidative stress conditions.Conclusion: The method was validated for accuracy, precision, linearity, specificity and robustness and revealed that it is specific, accurate, rapid, precise, reliable and reproducible enough to analyze commercial dosage forms as per ICH guidelines.
Authors and Affiliations
K. K. Pradhan, U. S. Mishra
Keywords
Related Articles
- EP ID EP578240
- DOI -
- Views 47
- Downloads 0
SIMULTANEOUS ESTIMATION OF FAMOTIDINE AND RABEPRAZOLE SODIUM: METHOD DEVELOPMENT AND VALIDATION BY UV-SPECTROPHOTOMETRIC METHOD
Objectives: Study aimed for the simultaneous estimation of Famotidine and Rabeprazole sodium at 263 nm, λmax of Famotidine and 284 nm, λmax of Rabeprazole sodium.Methods: Method development and validation were done by...
ACUTE AND SUB-ACUTE TOXICITY STUDY OF AQUEOUS METHANOLIC LEAF AND BARK EXTRACT OF DOLICHANDRONE ATROVIRENS
Objective: The present study was to evaluate the oral toxicity of acute and sub acute studies of methanol leaf and bark extract of Dolichandrone atrovirensMethods: In acute toxicity studies of aqueous methanolic Dolichan...
GROWTH, YIELD AND FATTY ACIDS RESPONSE OF OENOTHERA BIENNIS TO WATER STRESS AND POTASSIUM FERTILIZER APPLICATION
Objective: The objective of this research was to study the effects of water stress treatments (40, 60, and 80 % available soil moisture, ASM) and/or potassium application (0, 0.4 and 0.8 g/pot) on growth parameters, yiel...
DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC DETERMINATION OF CEFPODOXIME PROXETIL IN PURE AND TABLET DOSAGE FORMS THROUGH ION-PAIR COMPLEX FORMATION USING BROMOTHYMOL BLUE
Objective: A simple, direct and accurate spectrophotometric method has been developed for the determination of cefpodoxime proxetil (CEFP) in pure and pharmaceutical formulations by complex formation with bromothymol blu...
ANTIBACTERIAL AND ANTIOXIDANT ACTIVITIES OF METHANOLIC EXTRACT OF BAUHINIA RACEMOSA
Objective: To evaluate antimicrobial and in vitro [s1]Â antioxidant activities of methanolic extract of Bauhinia racemosa leaf.Methods: The antimicrobial activity was determined by the agar-well diffusion method. The ant...